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FDA 510(k), K091791, PROVANT SYSTEM, MODEL 4201
FDA 510(k), K091791, PROVANT SYSTEM, MODEL 4201
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510(K) Number: K091791
Device Name: PROVANT SYSTEM, MODEL 4201
Manufacturer: REGENESIS BIOMEDICAL, INC.
Device Classification Name: diathermy, shortwave, for use other than applying therapeutic deep heat
Regulation Number: 890.5290
Classification Product Code: ILX
Date Received: 06/17/2009
Decision Date: 04/07/2010
Regulation Medical Specialty: Physical Medicine
Device Name: PROVANT SYSTEM, MODEL 4201
Manufacturer: REGENESIS BIOMEDICAL, INC.
Device Classification Name: diathermy, shortwave, for use other than applying therapeutic deep heat
Regulation Number: 890.5290
Classification Product Code: ILX
Date Received: 06/17/2009
Decision Date: 04/07/2010
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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